MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC. (IRWINDALE) NAVISTAR® THERMOCOOL®; SIMILAR DEVICE NI75TCJH, PMA # P030031

Model Number D-1197-18-SI

Device Problem Insufficient Information (3190)

Patient Problems Paralysis (1997); No Code Available (3191)

Event Date 06/12/2017

Event Type  Injury  

Manufacturer Narrative

The product was discarded, therefore no product failure analysis can be conducted and device malfunction cannot be confirmed.Since no lot number was provided, no device history record (dhr) review could be performed.Concomitant products: carto 3 system (model# m-4800-01 serial# (b)(4)).Manufacturer's ref.No: (b)(4).

Event Description

During a clinical trial, sponsored by bwi, it was reported that a patient underwent an ablation procedure with a navistar® thermocool® catheter and suffered diaphragmatic paralysis.Post-procedure, the patient developed reduced mobility of the right hemidiaphragm.There is no information regarding interventions or extended hospitalization.Issue is ongoing and unchanged.Principal investigator assessed this event as probably procedure-related.

Manufacturer Narrative

Additional information was received on july 25, 2017.The patient was a (b)(6) female with a pre-procedure diagnosis of paroxysmal atrial fibrillation.Visitag force visualization feature was used during the procedure with the following parameters: 2-3 mm stability range and 3-5 sev stability time.The adverse event occurred one day post ablation.The physician¿s opinion on the cause of this adverse event is probably procedure related.No medical or surgical intervention was performed.The patient did not require extended hospitalization because of the adverse event.The diaphragmatic paralysis resolved without sequelae and the patient has since fully recovered with no residual effects.(b)(4).

Manufacturer Narrative

Additional information was received on 07/28/2017 that this account ((b)(6)) uses a smarttouch catalog # d132705.Per the additional information received, the device was updated from navistar thermocool catalog# ni75tcjhi to smart touch bidirectional catalog# d132705.The lot number remains unknown.(b)(4).

Manufacturer Narrative

Additional information was received on january 22, 2018, deactivating the dyspnea and thoracic pressure events which were previously reported.Manufacturer's ref.No: (b)(4).

• Brand Name: NAVISTAR® THERMOCOOL®
• Type of Device: SIMILAR DEVICE NI75TCJH, PMA # P030031
• Manufacturer (Section D): BIOSENSE WEBSTER, INC. (IRWINDALE); 15715 arrow highway; irwindale CA 91706
• Manufacturer (Section G): BIOSENSE WEBSTER, INC. (IRWINDALE); 15715 arrow highway; irwindale CA 91706
• Manufacturer Contact: joaquin kurz ; 33 technology drive; irvine, CA 92618 ; 9497893837
• MDR Report Key: 6691897
• MDR Text Key: 79236744
• Report Number: 2029046-2017-00226
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• Reporter Country Code: BE
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: D-1197-18-SI
• Device Catalogue Number: NI75TCJHI
• Device Lot Number: UNKNOWN_D-1197-18-SI
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/14/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other